ECSubmissionFee object

Fees for Ethical review mandatory

Yes

Waiver for academic (non-commercial) studies possible

Yes

Fees for Ethical review

Authorization fees (including fees for EC review):
• New Clinical Trial Submission:
580.000 HUF (approx. €1890.-)
(In case of Preliminary opinion of CEC: 261.000 HUF to CEC and 319.000 HUF to CA)
• Amendments:
110.000HUF (Approx. 360€)
• Non-interventional trials:
370,000 HUF (approx. €1200.-)

Official guidance on required fees

Fees are provide on OGYÉI website in section: Clinical trial submission procedure

Waiver for non-commercial trials: Applicable criteria are provided on OGYÉI website in section: Non-commercial clinical trials

Applicable national legal framework/ Reference

Schedule No. 1 to Act XCV of 2005

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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